BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 2023012 · Received February 24, 2011

    Report

    Report Number
    9617766-2011-00454
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    November 26, 2010
    Report Date
    February 24, 2011
    Manufacturer
    GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)
    Product Code
    JAA
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GE REP CONTACTED THE CUSTOMER BY PHONE AND DIRECTED REPAIR OF THE SYSTEM. THE CUSTOMER CLEARED THE FAULT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM WOULD NOT SAVE IMAGES. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8800 FLUOROSCOPIC X-RAY JAA GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1